Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder | NCT00461292 | Trialant
CompletedInterventionalPhase 3Updated Oct 2, 2015
Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
ClinicalTrials.gov ID
NCT00461292
Lead Sponsor
AllerganINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Phase 3
Enrollment
275Actual
Last Update Posted
Oct 2, 2015Estimated
Start Date
May 2007
Primary Completion Date
Mar 2010Actual
Completion Date
Apr 2010Actual
Brief Summary
The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients
Overactive Bladder
botulinum toxin Type A (200U)
botulinum toxin Type A (300U)
Normal saline (Placebo); botulinum toxin Type A (200U)
Normal saline (Placebo); botulinum toxin Type A (300U)
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
Inadequate response to anticholinergic medication used to treat overactive bladder
Exclusion Criteria:
History or evidence of pelvic or urologic abnormality
Previous or current diagnosis of bladder or prostate cancer